NCT02626247

Brief Summary

Nutrimemo aims to study the effect of a daily consumption of a mix of vitamin A and long chain n-3 Polyunsaturated Fatty Acids (PUFA) on the evolution of cognitive functions in healthy elderly subjects. The study is a randomized, double bind, parallel-groups (2 arms) placebo-controlled design.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Sep 2013

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

August 28, 2015

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 10, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

December 11, 2015

Status Verified

December 1, 2015

Enrollment Period

2.6 years

First QC Date

August 28, 2015

Last Update Submit

December 10, 2015

Conditions

Healthy

Keywords

elderly

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline of the episodic memory measured by CANTAB - Paired Associate Learning test (PAL)

    52 weeks

Secondary Outcomes (23)

  • Change From Baseline of the working memory measured by CANTAB - Spatial Span test (SSP)

    52 weeks

  • Change From Baseline of the executive function and spatial planning measured by CANTAB - One tone Touch Stockings of cambridge " (OTS)

    52 weeks

  • McNair scale

    52 weeks

  • Change from baseline of the Verbal fluency measured by Isaac verbal fluency test

    52 weeks

  • Montgomery et Asberg Depression Scale

    52 weeks

  • +18 more secondary outcomes

Study Arms (2)

Vitamin A + Long chain PUFA

ACTIVE COMPARATOR

The test product is a food supplement containing Vitamin A + Long chain Poly Unsaturated Fatty Acids (PUFA). It is presented as a hard shell capsule containing lipophylic nutrients.

Dietary Supplement: Vitamin A +Long chain PUFA

Placebo

PLACEBO COMPARATOR

The placebo is a capsule with same appearance and organoleptic properties as the active product, containing no active component.

Other: Placebo

Interventions

Vitamin A +Long chain PUFADIETARY_SUPPLEMENT

3 capsules per day, two capsules at breakfast and one capsule at lunch, with a glass of water.

Vitamin A + Long chain PUFA
PlaceboOTHER

3 capsules per day, two capsules at breakfast and one capsule at lunch, with a glass of water.

Placebo

Eligibility Criteria

Age60 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Independent subjects
  • Living at home non diagnosed as Alzheimer
  • Body Mass Index (BMI) 20-30 kg/m2 (limits included);
  • \< MMSE score ≤ 29
  • Logical memory subtest of the Wechsler Memory Scale (16-69 years battery) - sub-scores complying with the following:
  • Immediate recall score \< 29;
  • Delayed recall score \< 16;

You may not qualify if:

  • Evidence of actual major depressive disorder according to the module A of the Mini International Neuropsychiatric Interview (MINI);
  • Subject consuming food supplements likely to have an effect on memory or within less than 6 months;
  • Subject consuming high level of Vitamin A and/or Long chain n-3 PUFA evaluated by a food frequency questionnaire,
  • Restrictive or unbalanced diet (hypocaloric, vegetarian, vegan, …) self-declared at V0;
  • Alcohol consumption \> 4 glasses/day
  • Diabetes;
  • Cardiovascular disease diagnosed within less than 2 years, with the following exceptions: subjects with controlled (medicated) high blood pressure and/ or controlled (medicated) can be included;
  • Unbalanced thyroid disease;
  • Anti-depressant treatment stopped since less than 3 months or still ongoing;
  • Personal history of schizophrenia or other psychiatric disorders;
  • Ongoing neuroleptic treatment;
  • Uncorrected visual or auditory dysfunction (according to the volunteer's self-declaration);
  • Life threatening pathology (such as cancer) in remission for less than 1 year or still ongoing;
  • General anesthesia in the last 6 months or planned in the next 6 months;
  • Documented food allergy(ies), namely to one of the components of the study product;
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitary Hospital Center - USR 3413 SANPSY

Bordeaux, 33000, France

RECRUITING

Related Links

Study Officials

  • Véronique PALLET, Professor

    Laboratoire NutriNeuro INRA-Université de Bordeaux

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 28, 2015

First Posted

December 10, 2015

Study Start

September 1, 2013

Primary Completion

April 1, 2016

Study Completion

December 1, 2016

Last Updated

December 11, 2015

Record last verified: 2015-12

Locations

FR(1)